Unlikely partners reach out to AIDS patients

BY NICHOLAS ZAMISKA

The HIV/AIDS pandemic in Africa in tandem with a dearth of low-cost
treatment options has placed the peculiar marriage of industry,
university, and scientist at the epicenter of recent criticism.
Professors, along with others, have emerged as some of the most fervent
supporters of Bristol-Myers Squibb (BMS), commending the company's swift
action last week that dramatically cut drug prices in South Africa.

EUGENE WONG/YH

What would have made for strange bedfellows nearly 50 years ago,
BMS, Yale, and William Prusoff, a pharmacology professor, have been
wedded by the increasingly complex and capital-intensive process of
realizing a laboratory discovery's life-saving potential. The popular
image of the profit-minded pharmaceutical company pitted against the
academic's idealist vision of fighting disease, with the university
awkwardly occupying the middle ground, dominates public opinion. The
three parties involved say this is unfairand untrue.

Prusoff and his late colleague Tai-Shun Lin invented the drug d4T
(sold under the brand-name "Zerit"), which makes up one
part of the three-drug cocktail that has relegated HIV to a manageable
disease in many parts of the first world. Despite remarkable success
in affluent countries, the drug's high price of $10,000 to $15,000 per
year prevented most of Africa's afflicted population from reaping its
life-saving benefits.

With an estimated 25 of the 36 million HIV-positive people worldwide
in Africa, Doctors Without Borders (DWB), an international medical
humanitarian group backed by a group of law students, demanded that the
drug be made available at a reduced cost. Yale and BMS quickly came to
an agreement resulting in the Wed., Mar. 14 announcement offering the
drug in South Africa at around $1 a day, an agreement that Bob Laverty
spokesperson for BMS, said, "was not the result of pressure"
from DWB or from Yale.

Despite the apparent concession, Steven Berry, professor of economics,
says that since demand was initially so low in South Africa due to
the drug's exorbitant western prices, BMS will most likely forfeit
little profit. Instead, drug companies fear possible pressure from the
U.S. and Europe to lower inflated prices. Patients in affluent nations
are essentially footing the bill for the research of drug development.

Jon Soderstrom, director of the Office of Cooperative Research,
who has borne the brunt of much of the media's negative attention, is
"tired" of reporters who consistently supplant "balanced
reporting" with "good sound bytes." According to
Sod-erstrom, this brand of opportunistic censure of his office and the
companies with which he deals is misguided: "The pharmaceutical
industry is an easy target. But BMS took a very high risk on d4T 12 years
ago, a risk that has prolonged hundreds of thousands of lives,"
he said.

Prusoff champions the pharmaceutical industry for its critical role
in drug development. "These are good people who are serious about
fighting disease," he said. D4T would have been "shelved"
if it were not for a company like BMS who put up the estimated $500
to $800 million it costs to bring a drug to market. Such a large
sum accounts for the lost research money on drugs that fail the FDA's
requirements for safety testing.

In sum, the potential for profit on a drug like d4T compels firms to
front the necessary capital it takes to put a drug through its costly
clinical trials. Without such a monetary incentive, the development of
drugs would stall.

In 1948, drug patenting was rare and considered a threat to the
"interests of medicine and to the public," Prusoff remembered.

However, "things have changed since the '50s," Soderstrom
said. In 1962, Thalidomide, a new sleeping pill, was found to have caused
thousands of birth defects in European infants. The unmasked threat of
potentially harmful drugs prompted the Kefauver-Harris drug amendments
that required drug manufacturers to prove to the FDA the safety and
efficacy of their drugs. Thus, the FDA's emergence in the early '60s as a
powerful regulatory agency placed new demands on firms to fund expensive
checks on a previously lightly regulated pharmaceutical industry. Patents
became the vehicle by which companies generated the capital to fund the
costly FDA tests.

Soderstrom himself helped found the local biotech firm Achillion. In
part, Achillion's goal was to develop a possible Hepatitis B treatment
that was "sitting on the shelf" since there was no patent. No
firm would accept without exclusivity rights in the form of patent
protection. He recruited people from BMS to work on the development,
secured a patent for ACH-126,443 and is currently in clinical
trials. "None of this would have happened without the patent,"
according to Soderstrom.

Over the years, the line between industry and academia has grown
increasingly blurred, and many see this merge as critical to the
development of life-saving drugs. Nevertheless, professors will certainly
articulate their reasons for remaining at the university-level and
admonish administrators about a potential "direct involvement"
between their research and the drug companies' interests. Amy Kapczynski,
LAW '03, who organized fellow law students to pressure the University
into taking action on the d4T issue, calls the University's aggrandized
relationship with private industry "somewhat distressing" while
nevertheless acknowledging the "inevitable and necessary link"
between the two.

However, academic "freedom and liberty," as professors put
it, has its price too. Sartorelli criticizes the process of securing
multi-million dollar grants crucial to the funding of research as
"tremendously burdensome." He complains of the inordinate
amount of time he must devote to the "complex and competitive"
application process as a process that will, in his estimation, persist
for years to come. "It's simply the facts of life in academia,"
Sartorelli said.

Despite these arduous realities, Sartorelli and others have chosen
to pursue their passions as they see fit without the guidance of a
profit-minded executive keeping watch. Sartorelli, specializing in
anticancer therapies, is currently working on a group of 10 compounds
that are in the development and testing phase. Since the '50s, Prusoff's
lab has produced "dozens and dozens" of antiviral compounds
in which he had extreme faith. However, only two have successfully been
brought to market.

Contrary to popular belief, BMS has not singled out South Africa
for preferential treatment on a continent where nearly 70 percent of
the world's HIV-positive persons live. Every other country in Africa
is under no legal obligation to prevent the importation of low-priced
generic versions of d4T.

Despite mounting public pressure, BMS, along with 39 other major
drug companies, is still suing the South African government for passing
a law signed under the end of Nelson Mandela's presidency that would
greatly enhance the government's ability to secure the necessary drugs
in the face of an epidemic. BMS sees the lawsuit as a "separate
issue." Torgeson, a spokesperson for DWB, dubs this apparent
inconsistency "disingenuous" and demands that BMS drop the
lawsuit immediately.

While the legal battle in South Africa wears on, Yale might consider
revising its patent policy to include a "humanitarian clause"
to allow Yale to cancel its obligation to a drug company if Yale deemed
the firm's behavior as seriously running afoul of the "public
good." Both Soderstrom and Laverty say that such a clause would
certainly interfere with future investment in Yale's research program
while only providing "extraordinarily subjective" protection
for humanitarian interests.

Ironically, BMS still has not yet contacted DWB to inform them
personally of their newest policy initiative in South Africa.